Pembrolizumab

Generic Name: Pembrolizumab

Brand Names: Keytruda

Drug Type: Biotech

Chemical Formula: -

CAS Number: 1374853-91-4

Unique Ingredient Identifier: DPT0O3T46P

Background: Pembrolizumab is a highly selective IgG4-kappa humanized monoclonal antibody against PD-1 receptors. It was generated by grafting the variable sequences of a very high-affinity mouse antihuman PD-1 antibody onto a human IgG4-kappa isotype containing a stabilizing S228P Fc mutation. It contains 32 cysteine residues and the complete folded molecule includes 4 disulfide linkages as interchain bonds and 23 interchain bonds. It was developed by Merck & Co and first approved for the treatment of metastatic malignant melanoma by the FDA on September 4, 2014, becoming the first approved therapy against PD-1. In the time since its initial approval, pembrolizumab has been granted approval in the treatment of a wide variety of cancers.

Indication: Pembrolizumab is indicated for the following conditions:

For all approved adult indications, pembrolizumab may be used for an additional 6 weeks at 400mg weekly.

Associated Conditions: Advanced Endometrial Cancer, Advanced Renal Cell Carcinoma, Hepatocellular Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Locally Advanced or Metastatic Urothelial Carcinoma (UC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Cervical Cancer, Metastatic Esophageal Carcinoma, Metastatic Melanoma, Metastatic Non-Small Cell Lung Cancer, Metastatic Renal Cell Carcinoma ( mRCC), Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC), Metastatic Triple Negative Breast Cancers, Metastatic Urothelial Carcinoma (UC), Metastatic cutaneous squamous cell carcinoma, Metastic Renal Cell Carcinoma, Non-Small Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage II, Persistent Cervical Cancer, Recurrent Cervical Cancer, Refractory Primary Mediastinal Large B-Cell Cell Lymphoma, Renal Cell Carcinoma (RCC), Resectable Non-small Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIB Melanoma, Stage IIC Melanoma, Stage III Melanoma, Stage IIIA Non Small Cell Lung Cancer, Unresectable Melanoma, Advanced Microsatellite Instability High Endometrial Carcinoma, Advanced Mismatch Repair-deficient (dMMR) Endometrial Carcinoma, High risk, early Triple Negative Breast Cancer, High risk, in situ Non-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCG, Locally advanced Adenocarcinomas of the Gastroesophageal Junction, Locally advanced Esophageal Carcinoma, Locally advanced Urothelial Carcinoma, Metastatic HER2-positive Adenocarcinoma of the Stomach, Metastatic HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Metastatic High Tumor Mutation Burden Solid Tumors, Metastatic Merkel Cell Carcinoma (MCC), Metastatic Microsatellite Instability High Colorectal Cancer, Metastatic Microsatellite Instability-High (MSI-H) Solid Tumors, Metastatic Mismatch Repair Deficient Colorectal Cancer, Metastatic Mismatch repair deficient (dMMR) solid tumors, Recurrent Cutaneous Squamous Cell Carcinoma, Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent, locally advanced Adenocarcinomas of the Gastroesophageal Junction, Recurrent, locally advanced Merkel Cell Carcinoma, Refractory Classical Hodgkin's Lymphoma, Relapsed Classical Hodgkin's Lymphoma, Stage 3 Non-Small Cell Lung Carcinoma (NSCLC), Unresectable High Tumor Mutation Burden Solid Tumors, Unresectable Microsatellite Instability High Colorectal Cancer, Unresectable Microsatellite Instability-High (MSI-H) Solid Tumors, Unresectable Mismatch Repair Deficient Colorectal Cancer, Unresectable Mismatch repair deficient (dMMR) solid tumors, Unresectable, locally advanced HER2-positive Adenocarcinoma of the Stomach, Unresectable, locally advanced HER2-positive Adenocarcinomas of the Gastroesophageal Junction, Unresectable, locally recurrent Triple Negative Breast Cancer, Unresectable, recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Associated Therapies: -

Clinical Trials

Pembrolizumab and Lenvatinib After Definitive Chemoradiation of Locally Advanced HNSCC

Phase 2

Recruiting

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Lenvatinib

First Posted Date: 2022-06-27

Last Posted Date: 2024-08-02

Lead Sponsor: Universität des Saarlandes

Target Recruit Count: 50

Registration Number: NCT05433116

Locations: 🇩🇪
University Hospital Ulm, Otolaryngology & Head and Neck Surgery, Ulm, Baden-Württemberg, Germany
🇩🇪
University Hospital Düsseldorf, Radiation Oncology, Düsseldorf, Northrhine-Westphalia, Germany
🇩🇪
University Hospital Frankfurt/M, Center for Radiology, Frankfurt, Hesse, Germany

and more 7 locations

Liver SBRT in Combination With Immune Checkpoint Inhibition in Patients With Metastatic Non-small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Non-small Cell Lung Cancer
Liver Metastases

Interventions: Radiation: Liver SBRT
Drug: Pembrolizumab

First Posted Date: 2022-06-24

Last Posted Date: 2022-08-01

Lead Sponsor: VA Ann Arbor Healthcare System

Target Recruit Count: 12

Registration Number: NCT05430009

Locations: 🇺🇸
Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan, United States

Phase I Study of ZN-c3 and Bevacizumab ± Pembrolizumab in Metastatic CCNE1 Amplified and TP53 Mutant Solid Tumors

Phase 1

Withdrawn

Conditions: Tumors
Ovarian Cancer
Breast Cancer
Lung Cancer
Pancreatic Cancer

Interventions: Drug: ZN-c3
Drug: Bevacizumab
Drug: Pembrolizumab

First Posted Date: 2022-06-24

Last Posted Date: 2023-06-15

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT05431582

Study of SMT-NK Inj. Plus Pembrolizumab vs Pembrolizumab Monotherapy in Patients With Advanced Biliary Tract Cancer

Phase 2

Recruiting

Conditions: Biliary Tract Cancer

Interventions: Drug: SMT-NK inj.+Pembrolizumab
Drug: Pembrolizumab

First Posted Date: 2022-06-23

Last Posted Date: 2022-09-27

Lead Sponsor: SMT bio Co., Ltd.

Target Recruit Count: 128

Registration Number: NCT05429697

Locations: 🇰🇷
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of
🇰🇷
Severance Hospital, Seoul, Korea, Republic of
🇰🇷
Gangnam Severance Hospital, Seoul, Korea, Republic of

Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 Inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients With Advanced Triple-Negative Breast Cancer

Phase 1

Recruiting

Conditions: Anatomic Stage III Breast Cancer AJCC v8
Unresectable Triple-Negative Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma
Locally Advanced Triple-Negative Breast Carcinoma

Interventions: Drug: BET Bromodomain Inhibitor ZEN-3694
Procedure: Biospecimen Collection
Procedure: Biopsy
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Nab-paclitaxel
Biological: Pembrolizumab

First Posted Date: 2022-06-21

Last Posted Date: 2024-12-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 57

Registration Number: NCT05422794

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States

Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System

Phase 2

Withdrawn

Conditions: Recurrent Endometrial Cancer
Solid Tumors

Interventions: Drug: pembrolizumab
Drug: Sitravatinib

First Posted Date: 2022-06-15

Last Posted Date: 2023-02-27

Lead Sponsor: Haider Mahdi

Registration Number: NCT05419817

A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

Phase 2

Recruiting

Conditions: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Head and Neck Neoplasms
Head Cancer
Throat Carcinoma

Interventions: Drug: Pembrolizumab
Drug: Carboplatin
Drug: Paclitaxel

First Posted Date: 2022-06-15

Last Posted Date: 2024-12-05

Lead Sponsor: University of Chicago

Target Recruit Count: 30

Registration Number: NCT05420948

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

A Study to Assess YH003 in Combination with Pebolizumab and Albumin Paclitaxel Injection in Subjects with Unresectable/metastatic Mucosal Melanoma

Phase 2

Completed

Conditions: Mucosal Melanoma

Interventions: Drug: YH003
Drug: Pembrolizumab
Drug: albumin paclitaxel

First Posted Date: 2022-06-15

Last Posted Date: 2025-01-06

Lead Sponsor: Eucure (Beijing) Biopharma Co., Ltd

Target Recruit Count: 20

Registration Number: NCT05420324

Locations: 🇨🇳
Cancer Hospital of Fujian, Fuzhou, Fujian, China
🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China
🇨🇳
Cancer Hospital of Zhenzhou, Zhengzhou, Henan, China

and more 9 locations

A Study of D3S 001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Phase 1

Recruiting

Conditions: KRAS P.G12C

Interventions: Drug: D3S-001
Drug: Pembrolizumab
Drug: Cisplatin
Drug: Cetuximab
Drug: Carboplatin
Drug: Pemetrexed

First Posted Date: 2022-06-08

Last Posted Date: 2024-12-27

Lead Sponsor: D3 Bio (Wuxi) Co., Ltd

Target Recruit Count: 392

Registration Number: NCT05410145

Locations: 🇪🇸
D3 Bio Investigative Site, Valencia, Spain

Pembrolizumab in Muscle-invasive Bladder Cancer

Phase 2

Recruiting

Conditions: Muscle Invasive Bladder Carcinoma
Localized Cancer
Urothelial Carcinoma

Interventions: Drug: Pembrolizumab

First Posted Date: 2022-06-06

Last Posted Date: 2024-10-11

Lead Sponsor: Matthew Galsky

Target Recruit Count: 46

Registration Number: NCT05406713

Locations: 🇺🇸
Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸
Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
🇺🇸
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States

and more 1 locations

Drug Development Updates

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